FDA approves furosemide on-body infusor for pediatric patients weighing 43 kg or more

On December 23, 2025, the FDA approved an expanded indication for furosemide injection (FUROSCIX; MannKind) on-body infusor to include pediatric patients who weigh 43 kg or more. The expansion follows the previously approved indication to treat edema associated with chronic heart failure (CHF) and chronic kidney disease (CKD) in adults, according to a press release from MannKind.^1,2

The indication expansion fulfilled all post-marketing requirements outlined in the original approval letter, per the Pediatric Research Equity Act.

“We are pleased to make FUROSCIX available to the pediatric population, a highly specific patient group, offering a convenient option outside the hospital setting for those who meet the weight criteria,” said Ajay Ahuja, MD, MBA, chief medical officer, MannKind Corporation, in a statement.

Officially, furosemide injection 80 mg / 10 mL is now approved for subcutaneous use and indicated to treat edema—congestion, fluid overload, or hypervolemia—in pediatric patients who weigh 43 kg or more, and adult patients with CHF or CKD, including the nephrotic syndrome.

On March 6, 2025, scPharmaceuticals (later acquired by MannKind) announced the expanded approval of FUROSCIX to include edemia treatment in patients with CKD, with availability beginning in April 2025.²

“Expanding the FUROSCIX indication to include patients with chronic kidney disease will provide a much-needed additional tool for clinicians to utilize in our management of fluid overload,” stated Suneel Udani, consulting physician at Nephrology Associates of Northern Illinois and Indiana, at the time of approval. "Utilizing FUROSCIX can potentially help us keep our patients with heart failure and/or CKD at home while we restore and maintain euvolemia.”

According to MannKind, the injection is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide, any component of the formulation, or medical adhesives. Additionally, the company noted that furosemide could cause fluid, electrolyte, and metabolic abnormalities, particularly in patients on higher doses, those with inadequate oral electrolyte intake, and elderly patients.

References:

1. MannKind shares FUROSCIX business updates. MannKind. Press release. December 23, 2025. Accessed December 23, 2025. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-shares-furoscixr-business-updates
2. scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the FUROSCIX® Indication to Include the Treatment of Edema in Patients with Chronic Kidney Disease. scPharmaceuticals. Press release. March 6, 2025. Accessed December 23, 2025. https://www.globenewswire.com/news-release/2025/03/06/3038597/0/en/scPharmaceuticals-Announces-FDA-Approval-of-Supplemental-New-Drug-Application-Expanding-the-FUROSCIX-Indication-to-Include-the-Treatment-of-Edema-in-Patients-with-Chronic-Kidney-Di.html